UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040972 |
|---|---|
| Receipt number | R000046725 |
| Scientific Title | Development of a novel method for prognostic prediction and precision medicine in pancreatic adenocarcinoma using fine-needle biopsy tissues collected from intraoperative specimen: A two-center, double-blind, randomly allocated comparative study |
| Date of disclosure of the study information | 2020/07/03 |
| Last modified on | 2023/05/20 21:43:31 |
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Basic information
Public title
Development of a novel method for prognostic prediction and precision medicine in pancreatic adenocarcinoma using fine-needle biopsy tissues collected from intraoperative specimen
Acronym
Development of a novel method for prognostic prediction and precision medicine in pancreatic adenocarcinoma using fine-needle biopsy tissues collected from intraoperative specimens
Scientific Title
Development of a novel method for prognostic prediction and precision medicine in pancreatic adenocarcinoma using fine-needle biopsy tissues collected from intraoperative specimen: A two-center, double-blind, randomly allocated comparative study
Scientific Title:Acronym
Development of a novel method for prognostic prediction and precision medicine in pancreatic adenocarcinoma using fine-needle biopsy tissues collected from intraoperative specimen
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To development possible judgement of prognosis and taylor-made chemotherapy for pancreatic cancer using fine needle aspiration tissue from operatively extracted specimen, we evaluate the correlation between immunohistochemistry-score and a novel quantitative analysis for Smad4.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the correlation between immunohistochemistry-scores and novel quantitative analysis for Smad4.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Quantitative measurement of Smad4 protein
Interventions/Control_2
FNB immunostaining pathology judgement
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pantients with pancreatic cancer who undergo surgery including pancreaticoduodenectomy, distal pancreatectomy, and total pancreatectomy, afte pancreatic cancer is suspected by objective finding (e.g., US, Abdominal CT, Abdminal MRI)
2. more than 20 years old
3. Patients provided written informed consent to participate in this study.
Key exclusion criteria
1. Inoperable case (e.g., caricninomatosa was found out) during surgery.
2. Patient with mental disease and it is difficult to participate in study.
3. Patints who refuse to participate in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo , Japan
TEL
03-3433-1111
ccl09720@gmail.com
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Chiba |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo , Japan
TEL
03-3433-1111
Homepage URL
ccl09720@gmail.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self-funding (The Jikei University School of Medicine)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Committee of Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
+81 3 34331111, ext. 2134
rinri@jikei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京慈恵会医科大学 附属病院 葛飾医療センター
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 07 | Month | 01 | Day |
Last modified on
| 2023 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046725
